The Fully Automated HbA1c Analyzer-------LD-560
The Fully Automated HbA1c Analyzer is used in conjunction with suitable reagents for the quantitative detection of glycosylated hemoglobin (HbA1c) in human blood
Using high performance liquid chromatography (HPLC), the stationary phase used is a weakly acidic cation exchanger. Glycosylation of hemoglobin will result in the loss of cations on the surface of hemoglobin without being charged, and non-glycosylated hemoglobin has a positive charge. According to the different charged properties of hemoglobin, eluents with different pH values and ionic strengths are used sequentially, and several hemoglobin components including HbA1c are separated by high performance liquid chromatography. Each component is detected by a single-wavelength colorimeter, and the detected data is processed by a computer to calculate the percentage content of HbA1c in the total hemoglobin.
Accuracy: The accuracy is tested with reference materials as samples, and the relative deviation of the test results should be within ±5%.
Repeatability: For samples with a test concentration of 4%-6%, the sample coefficient of variation (CV) of the test results is not greater than 2.0%.
Linear range: Within the range of 3%-18% of glycosylated hemoglobin, the linear correlation coefficient R value of the test results should not be less than 0.9900.
Stability: Within 8 hours after the analyzer is turned on and stabilized, the same normal sample is tested, and the relative deviation of the test results is not more than ±3.0%.
Carrying pollution: The carrying pollution rate of the analyzer should not be greater than 2.0%.
LABNOVATION TECHNOLOGOES, INC was established in 2001 and has been recognized as a "National High-tech Enterprise". The registered capital (including its wholly-owned subsidiaries) is RMB 20 million, and it is one of the earliest companies exporting in vitro diagnostic reagents in China. The product sales network has covered more than 110 countries and regions around the world.
It is the first in the industry to pass the ISO9001:2008.ISO13485:2012/AC:2012 quality system TUV certification, and obtain the EU CE certification and FDA certification.
The company invests more than 10% of its sales into product research and development, hardware construction and update every year, and 85% of the company's R&D team employees have more than 5 years of industry experience.